Omni Hysteroscope, Omni Lok cervical seal
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191281 FDA 510(k)
- FDA Product Code
- HIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Omni Hysteroscope with Omni Lok Cervical Seal is a diagnostic and therapeutic device classified as a Hysteroscope (and Accessories). It is designed for visual inspection and intervention within the uterine cavity, providing a clear view of the endometrial lining and cervical canal while maintaining hemostasis through a cervical seal mechanism. The device combines optical imaging with a sealing system to reduce fluid leakage and improve procedural stability during hysteroscopic examinations or interventions.
This device is supplied as a reusable system, intended for use in clinical settings such as outpatient clinics, hospitals, or surgical centers. It is not sterile at the time of shipment but is intended to be sterilized prior to use, adhering to standard medical device reprocessing protocols. The Omni Lok Cervical Seal is engineered to minimize cervical trauma and fluid extravasation, enhancing patient comfort and procedural efficiency. Regulatory authorizations include FDA 510K clearance and MDR compliance, with classification under Class II medical devices for obstetrics/gynecology applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191281 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA 510(k) K191281 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026